On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more
On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food labels. The new rule uses current nutrition science to both expand and restrict...more
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more
1/15/2025
/ Clinical Trials ,
Compliance ,
Corporate Governance ,
Data Integrity ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Pharmaceutical Industry ,
Regulatory Authority ,
Regulatory Requirements ,
Securities Regulation ,
Shareholders ,
Warning Letters